Recruiting NCT07299851
Oral Supplementation With a Formulation Based on Cetylated Fatty Acids for Post-fracture Long Bone Healing
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CFA-based food supplement, Placebo.
- Who it may be relevant to
- Registry conditions: Fracture Femur, Fracture Tibia. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Randomized, Double-blind, Placebo-controlled Study With 12 Weeks Oral Supplementation With a Formulation Based on Cetylated Fatty Acids to Support the Early Stage of Long Lower Limb Bone Healing After Fracture Stabilization
Overview
This clinical study aims to evaluate the potential benefits of a formulation based on Cetylated Fatty Acids in improving fracture healing of long bones in the lower limbs. The investigational product is administered orally over a 12-week period. Study procedures are limited to standard imaging techniques (radiography and echography), blood sampling, and completion of validated quality of life questionnaires.
Interventions
- Dietary supplement CFA-based food supplement
oral gel containing cetilated fatty acids - Other Placebo
oral gel coloured and flavoured as the IP
Primary outcome measures
- Radiographic Assessment of Callus Formation using the modified Radiographic Union Score for Tibia (mRUST). [Time frame: 6 weeks after fracture stabilization]
Secondary outcome measures (12)
- Pain Assessment at Fracture Site using the Visual Analog Scale (VAS) [Time frame: 4 weeks after fracture stabilization]
- Ultrasonographic Assessment of Callus Formation [Time frame: 4 weeks after fracture stabilization]
- Radiographic Assessment of Callus Formation (modified Radiographic Union Score for Tibia - mRUST) [Time frame: 12 weeks after fracture stabilization]
- Pain Assessment at Fracture Site (Visual Analog Scale - VAS) [Time frame: 12 weeks after fracture stabilization]
- Incidence of Complications [Time frame: 4 weeks and 12 weeks after fracture stabilization]
- Minimal Clinically Important Improvement (MCII) [Time frame: 4 weeks and 12 weeks after fracture stabilization]
- Participant Acceptable Symptom State (PASS) [Time frame: 4 weeks and 12 weeks after fracture stabilization]
- Participant Global Assessment (PGA) [Time frame: 4 weeks and 12 weeks after fracture stabilization]
- Lower Extremity Functional Scale (LEFS) [Time frame: 4 weeks and 12 weeks after fracture stabilization]
- Quality of Life using the Short Form-36 (SF-36) questionnaire. [Time frame: 4 weeks and 12 weeks after fracture stabilization]
- Painkiller and NSAID Consumption [Time frame: 4 weeks and 12 weeks after fracture stabilization]
- Incidence of Adverse Events (AE) and Serious Adverse Events (SAE) [Time frame: 4 weeks and 12 weeks after fracture stabilization]
Eligibility criteria
Inclusion criteria
- Between 18 and 85 years old
- Presence of simple closed unifocal fracture (transverse, oblique, spiral, butterfly-shaped) in a long bone which need a standard of care surgical stabilization
- Presence of diaphyseal fracture of lower limb (femur or tibia, Subtrochanteric fracture are also allowed)
- Presence intramedullary nail
- Weight bearing as tolerated after surgery
- Having signed an informed consent, understand study procedures and ability to follow them
- Agreed to stop vitamin D intake for participants who take prophylactic Vitamin D
Exclusion criteria
- Treatment with vitamin D for medical purpose (Non-union, osteoporosis…)
- BMI > 30
- Open fracture
- Intra articular fracture
- Metaphyseal fracture
- Polytrauma patient (injury severity score: ISS >= 16)
- More than one lower limb long bone fracture
- Bridging plate
- Fracture treated conservatively with plaster
- Presence of active infection (body temperature ≥ 38°C or other symptoms)
- Any sign of severe vascular compromise across the fracture site (such as compartment syndrome, presence of serious vascular damage, etc.)
- Pathological fracture or diseases with a risk of recurrent falling (e.g. Parkinson's disease/syndrome, Hemiplegia after stroke, symptomatic stenosis of the spinal canal, polyneuropathy, epilepsy, recurring vertigo, recurring syncope)
- Participants with known bone disease which would negatively impact on the bone healing process
- Participants currently being treated with radiation, chemotherapy, immunosuppression, or steroid therapy
- Diabetic participants
- Daily smoker participants (cigarette or vaping containing nicotine)
- Participants under cortisone intake
- Participants under rheumatic medications intake
- Allergy or adverse effect of food supplement composition
- Unwilling or unable to take study medication
- Chronic drug or alcohol abuse
- Pregnant or breastfeeding at the time of enrolment
- Any other investigational treatment or food supplement within 3 months.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Belgium · 6 centers
- AZ Monica — Deurne
- Algemeen Ziekenhuis Herentals — Herentals
- Hôpital Erasme - Cliniques Universitaires de Bruxelles — Brussels
- Universitair Ziekenhuis Brussel — Brussels
- Universitair Ziekenhuis Gent — Ghent
- Ziekenhuis Oost-Limburg — Genk
Identifiers
NCT: NCT07299851 · CETI ULTRA-BONE